regulatory information management systems (RIMS)

RIMS Industry Perspective

An important industry trend is health authorities' changing regulations for data-oriented information exchange. Although paper-based processes have been largely phased out, data requirements have only become more sophisticated.

One example is the European Medicine Agency's Identification of Medicinal Products (IDMP) mandate, which introduces new stipulations on data elements and structures to uniquely identify medicinal products and substances. Organizations seeking to comply with IDMP must have established processes for data collection and evaluation. They may also need to perform remediation.

What is Regulatory Information Management (RIM)?

Regulatory Information Management is a set of processes used to collect, manage, and archive information in accordance with regulatory requirements. For life science companies, RIM can be a complex, time-intensive effort, but it is essential to ensure compliance and protect patients.

RIM comprises all information that is required by regulators to ensure safety, efficacy, and product quality. Examples include clinical trial information, safety data, manufacturing specifications, labeling information, marketing materials, regulatory submissions, and health authority correspondence.

RIMS Software Vendors

There are numerous RIMS vendors in the life sciences space, all of which generally provide submission tracking, workflow automation, and document version control capabilities. We've listed three well-known solutions below:

• Documentum for Life Sciences (OpenText): Cloud-native platform that includes module specific to submission/correspondence storage and viewing. Accessible via web or mobile. Unique features include flexible upgrade timing and the ability to choose your preferred cloud infrastructure. 
• EXTEDOpulse (EXTEDO): Comprehensive RIMS solution with five modules: Planning and Tracking, Document Management, Registration Management, Safety Management, and Submission Management.  
• Veeva Vault RIM Suite (Veeva Systems): Cloud-based platform comprising four distinct applications: Submissions, Submissions Archive, Registrations, and Publishing. Vault Submissions has been adopted by 100+ organizations and is popular among enterprise companies.